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Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors. Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics. CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.

This document focuses on the 510(k) summary for the "Confident Surgery Suite 300 (CSS300)" system and primarily discusses its intended use and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot fully complete the table and answer all questions as the requested information is not present in the provided text.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document lists safety standards met (EN 60601-1, UL 60601-1, EN 60601-1-2:2007) and indicates CE Mark compliance, which are general regulatory requirements, not specific performance acceptance criteria for the imaging capabilities.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI in the context of improving human reader performance. The CSS300 is described as an "extension for nuclear uptake detectors designed to obtain 3D images" and "make their use more intuitive and thus enable better patient treatment," but it doesn't describe AI-assisted interpretation. Therefore, this information is not present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "working in conjunction with a nuclear uptake detector" and generating images for interpretation by "trained personnel." This implies a human-in-the-loop system. There is no mention of a standalone algorithm performance study. This information is not present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided document.

8. The sample size for the training set

This information is not present in the provided document.

9. How the ground truth for the training set was established

This information is not present in the provided document.

Summary of what is available from the document:

• Device Name: Confident Surgery Suite 300 (CSS300)
• Intended Use: Extends nuclear uptake detectors to generate 3D images of radionuclide distribution in the human body using tracking technologies and image reconstruction. Images are for documentation and reporting, and interpretation is by trained personnel.
• Regulatory Basis: 510(k) clearance based on substantial equivalence to predicate devices (Neoprobe Model 1500, SI-Handheld Gamma Finder, VectorVision2, Nexstim Eximia).
• Technology: Combines nuclear uptake detection with an infrared tracking system and image reconstruction.
• Safety Standards: Meets EN 60601-1, UL 60601-1, EN 60601-1-2:2007, and bears the CE mark.

To provide the requested details, a different type of document, such as a validation study report, clinical trial summary, or a more detailed section of the 510(k) submission focusing on performance characterization, would be required.

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The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.

Spinal Procedures: Spinal implant procedures such as pedicle screw placement.

ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

The VectorVision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.

This 510(k) summary describes a modification to the VectorVision Frameless Biopsy System, a medical device designed for image-guided surgery. However, the provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

The document details the device's intended use and substantial equivalence to previously cleared devices. It states:

• Product: VectorVision Frameless Biopsy System
• Manufacturer: BrainLAB AG
• Indications for Use: Intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data (CT, X-ray, or MR). It is indicated for medical conditions where stereotactic surgery is appropriate and a reference to a rigid anatomical structure (skull, long bone, vertebra) can be identified. Examples include cranial (biopsies, tumor resections), spinal (pedicle screw placement), and ENT procedures.
• Modification: The new features are aimed at improving support and guidance of surgical instruments. A multiarticulated arm facilitates the use of various instruments for serial approaches or guiding a single instrument to multiple targets along the same trajectory. This, combined with existing IGS features, simplifies trajectory determination and locating. Mechanical support can limit instrument degrees of freedom, providing stability and alleviating the surgeon's task.
• Substantial Equivalence: The device was found substantially equivalent to BrainLAB's VectorVision2 System (K983831, K003589).

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The 510(k) summary focuses on the device's intended use and its substantial equivalence determination, rather than detailed performance study results against predefined acceptance criteria.

To provide the requested information, a separate performance study report or a more detailed section within the 510(k) describing validation testing would be necessary.

Ask a specific question about this device